The assessment of the internal biological environment of a patient has its beginnings in Europe and is derived from clinical research performed by Louis Claude Vincent. Professor Vincent believed that the key to healing the body was evaluating the biochemistry of a patient. Professor Vincent spent years gathering and evaluating human clinical data which persuaded him that the building blocks of life, to wit, amino acids, enzymes, molecules and atoms found within body fluids provided vital data about the way that particular body was actually functioning. By monitoring the values of pH, oxidation-reduction potential (hereinafter "redox") and resistivity of these body fluids and making changes thereto when necessary, health and vitality could be established in a patient that assisted the patient in naturally fending off illness and disease.
Many fields of medicine simply examine, isolate or treat one particular system or part of a body. In contrast, the assessment of the internal biological environment requires clinical monitoring of the entire body. The goal is to understand the elements within a given patient's chemistry and prescribe the exact form of treatment to allow that patient to regain and maintain a healthy internal biochemical environment. Doing so at the chemical level translates, in time, to vitality and health to every cell, tissue, organ and gland within a patient's body. Since every human body is unique, every ailment must be treated in the context of that particular body. Even patients that display similar conditions such as arthritis or pre-menstrual syndrome may present internal biological environments that differ significantly thus requiring significantly different treatment plans.
Many patients who initially undergo the internal biological environment assessment present reports of normal laboratory results yet display symptoms of illness both subjective and objective. The testing of the internal biological environment may yield data which points to subtle yet potent influences such as parasites, viruses, fungi pollutants, zenobiotics, invasive micro-organisms, free radicals, inadequate vitamins and minerals, an insufficiency of oxygen or an inability to excrete carbon dioxide properly which point to the underlying cause of the patient's illness. However, most standard laboratory tests are inadequate for detecting or measuring such data.
The assessment of a patient's internal biological environment preferably uses that patient's urine, venous blood, and saliva. The patient will undergo a 12-14 hour fast and avoid the use of toothpaste, mouthwash or lipstick which can alter the chemistry of the mouth (saliva). The patient will need to collect his or her first morning urine as a sample. Small amounts (1.5 mL) of venous blood and saliva are collected in the office performing the assessment.
The fluids are tested for pH which is essentially an analytical measurement of the activity and potential energetics of the hydrogen ion. pH is related to the hydrogen ion concentration by the equation: EQU pH=log(1/H.sup.+ Conc.)=-log H.sup.+ Conc.
When expressed as shown, the concentrations can be placed on the classic pH scale of 0 to 14.4. When the H.sup.+ concentration increases, the pH decreases creating a condition known as acidosis whereas when the H.sup.+ concentration decreases, the pH increases creating a condition known as alkalosis. The terms acidosis and alkalosis refer to the relative concentrations of an acid versus a base. Excess acid in relation to a base results in acidosis while excess base in relation to acid results in alkalosis.
There are a number of acids and bases that function in a biological capability. The acids include, but are not limited to, hydrochloric acid, carbonic acid, acetic acid, uric acid, phosphoric acid and nitric acid. The bases include, but are not limited to, bicarbonate ions, sodium bicarbonate, sodium phosphate, special inter-cellular proteins and hemoglobin.
A number of vital pH measurements have been made on various body fluids which define the definitive biochemical balance within a human body. A chart is provided which details the pH measurement ranges for various body fluids:
______________________________________ TISSUE OR FLUID pH RANGE ______________________________________ Saliva 6.0-7.0 Gastric secretion 1.0-3.5 Pancreatic secretion 8.0-8.3 Bile 7.8 Small intestinal secretion 7.5-8.0 Urine 4.5-8.0 Arterial blood 7.4-7.45 Capillary blood 7.35-7.4 Venous blood 7.3-7.35 ______________________________________
As shown, the pH ranges for the listed fluids falls within a relatively narrow range. If the pH values vary outside this range, cellular function diminishes which may lead to death of the organism Consequently, the body has developed numerous and elaborate systems known as acid-base buffer systems, to regulate and maintain the above pH levels.
In general, a buffer is a solution containing two or more chemical compounds which prevent significant alterations in pH regardless of whether an acid or a base is added to the solution. The buffer systems most active in a body are the bicarbonate/carbon dioxide system, the extracellular system which is mainly comprised of the relative concentration of phosphate, the intercellular system (intercellular proteins/hemoglobin) and bone. While these buffer systems are very effective, variances in the pH levels do often occur.
Most often, such variations are the result of the constant bombardment of the body by acids, both from internal metabolic sources as well as exogenous sources. Acids are formed internally as a normal function of cellular metabolism This normal acid production increases during, for example, times of stress and during exercise. The culprit for excess acid production is the oxidation of fats, carbohydrates and proteins.
The typical American adult consumes over 150 milliequivalents (mEQ) of acids. If the body is unable to process this acid, the body must store the acid. The initial area is the interstitial cells or matrix which is the most biologically benign area for acid storage. However, if this area becomes saturated with acid, other areas used for storage are less benign. As the body becomes loaded with acid, metabolism, respiration, and enzyme kinetics are greatly affected, generally leading to pathology. This pathology can effect the digestive, immune and lymphatic systems.
It should be apparent from this abbreviated discussion that a simple, accurate assessment of the varying fluid pH levels can provide valuable information as to the health of the patient being evaluated.
The second factor to properly assess the biological environment is termed oxidation-reduction potential (redox). Redox is a measurement of the ability of the tested system to gain or lose electrons until it reaches a state of equilibrium. A system which donates electrons is considered to be a reducing system while a system which accepts electrons is considered to be an oxidizing system. In living tissue, oxidation-reduction systems can be divided into two types which can occur either simultaneously or consecutively, namely:
1) those in which the oxidized and reduced forms differ solely in the number of electrons, and PA1 2) those in which "hydrogen transfer" occurs. PA1 E=oxidation-reduction potential in millivolts PA1 E.degree.=the standard potential occuring when all activities are equal PA1 R=the gas constant PA1 T=temperature in degrees Kelvin PA1 F=Faraday's constant or the number of electrons reacting
When a metal electrode is placed into a solution containing a reversible oxidation-reduction system, the electrode will analytically measure the oxidation-reduction potential. The measurement is generally in the range of millivolts and is represented by the letter E. The general equation is: EQU Reduced substance Oxidized substance+electron=E
If E is positive, the reaction has a greater tendency to occur in the direction that the arrow is drawn and hence favors the oxidized state. If, however, E is negative, the reaction has a greater chance to occur in the direction opposite the arrow and hence favors the reduced state. Examples of both are presented below: EQU Na Na.sup.+ +e.sup.- =2.71 mV (favors oxidized state) EQU Ag Ag.sup.+ +e.sup.- =-0.80 mV (favors reduced state)
The biological purpose of oxidation and reduction is two fold. First, oxidation and reduction creates high cellular energy in the form of adenosine triphosphate (ATP). Second, oxidation and reduction is used to oxidize or burn up invading pollutants, xenobiotics and some micro-organisms. Failure of the body to accomplish both purposes would quickly deplete the body of the energy needed to function and would result in serious pathology due to the inability of the body to rid itself of invaders.
When body fluids are loaded with electrons and have a negative E value, the potential for life giving reactions is highest. If the E value becomes more positive, the potential is minimized. Thus, assessing the E value provides tangible analytical evidence as to the energetics and life sustaining properties of a body fluid.
In a measurement, instead of E the analytic tool measures a quantity called rH.sub.2 which represents the partial pressure of hydrogen on the electrode. rH.sub.2 is calculated from the Nernst equation: EQU E=E.degree.+2.3(RT/F)log(H.sup.+ /rH.sub.2)
where:
solving the equation for rH.sub.2 results in a scale in values ranging from 0 to 42 where 0 corresponds to the maximal hydrogen partial pressure of 1 bar and 42 corresponds to the minimal hydrogen pressure of 1.times.10.sup.-42 bar. The midpoint of the scale is at rH.sub.2 =28 at which point the concentration of reductants equals the concentration of oxidants. An rH.sub.2 less than 28 represents a reduced state while a value over 28 represents an oxidized state.
The optimal values for pH of biological fluids are well known and clearly documented. However, the optimal values for rH.sub.2 are less accessible and subject to some debate. Listed in the following table are values derived from the work of Professor Vincent as well as values corrected as described in the present application:
______________________________________ FLUID Vincent rH.sub.2 Greenberg rH.sub.2 ______________________________________ Saliva 22 20.0 Urine 24 20.6 Blood 22 21.7 ______________________________________
The third factor evaluated in an assessment of the internal biological environment of a patient is resistivity which is the ability of a fluid's ability to conduct an electrical current. If an electrical current can pass easily and readily through the fluid, the resistivity is considered to be low. If, however, an electrical current has a great deal of difficulty passing through the solution, then the resistivity is very high. The factor which determines whether or not a fluid is electrically resistant is the relative concentration of electrically conductive ions, which, in the body, are present in the form of mineral salts. If the relative concentration of mineral salts is high, the resistivity will be low and vice versa. Resistivity is a measurement of the concentration of ions in the fluid and is expressed in units of ohms/centimeter.
As in any biological system, a balance or set concentration of mineral salts is essential to allow the system to carry out its many complex chemical reactions. If the concentration deviates from the norm, then the underlying biochemical functions are greatly affected. Excess mineral salts are removed from the body via the kidneys and urine. If the body loses too many salts or does not remove enough salts, the body will become toxic and underlying function will suffer. Osmotic gradients, cellular integrity, chemical reactivity and proper neurological function are all dependent upon proper mineral salt balance. Thus, resistivity provides indications of blood purification, kidney excretion, enzymatic concentration, dietary factors and alkaline reserve potential can be evaluated.
The optimal values for the resistivity of some body fluids were derived by Vincent and are given in the following chart:
______________________________________ FLUID Vincent resistivity ______________________________________ Saliva 180-220 Urine 30-45 Blood 190-210 ______________________________________
To summarize, there exists a strong interrelationship between the values of pH, rH.sub.2 and resistivity. All three parameters are necessary to provide an accurate picture of the internal biological environment of a patient. It must be emphasized that measurement and evaluation of the above three parameters do not diagnose any specific pathology or disease. These parameters are guideposts to aid in the overall evaluation of a patient. The purpose of the evaluation is threefold.
First, the evaluation allows the practitioner to document a reference point to determine if a methodology selected for therapeutic purposes is appropriate. Second, the evaluation provides the practitioner with a teaching guide to share with a patient which allows the patient to take an active role in his or her own health care. Lastly, the parameters provide the practitioner with immediate, easily ascertainable information that is irreplaceable in helping to determine the need for specific laboratory assays.
There have been a number of devices similar to the present invention in the prior art. For example, the present inventor has marketed a device known under the name BTA S1000 which used a dip style electrode in an open environment without temperature compensation. The solid pen style electrodes were not removable. The dip style electrodes tended to trap air bubbles which affected the accuracy and repeatability of measurements. The electrodes of the prior device were manufactured of a commercially available Plexiglas.RTM. material.
U.S. Pat. No. 2,886,771 entitled "Fluid-Testing Device" which issued on May 12, 1959 to Vincent (whose contributions to the field were discussed above) discloses a device for testing fluids such as blood, urine, spinal fluid and the like for pH, resistivity and redox. There is a thermostat for maintaining a constant temperature. Note FIGS. 5 and 6 where a syringe is used to draw fluids across a series of electrodes.
U.S. Pat. No. 4,786,394 entitled "Apparatus for Chemical Measurements of Blood Characteristics" which issued on Nov. 22, 1988 to Enzer et al. shows an apparatus for measurement of blood characteristics. Blood is routed through a flow chamber having a vertically aligned array of electrodes. The electrodes are in communication with a microprocessor having a display.
U.S. Pat. No. 5,046,496 entitled "Sensor Assembly For Measuring Analytes in Fluids" which issued on Sep. 10, 1991 to Betts et al. discloses another cell in which a syringe draws fluid across a series of electrodes then expels the fluid.
U.S. Pat. No. 4,844,887 entitled "Automatic Analyzing Apparatus" which issued on Jul. 4, 1989 to Galle et al. shows an analyzing apparatus in which fluids are drawn by syringe 179 across electrodes 183. Valve 180 is opened and pump 182 evacuates the fluid to tank 181.
U.S. Pat. No. 4,686,011 entitled "Method for the Protection of and/or Monitoring of Changes in a Reference System in Analytical Measuring Engineering, and Reference System with a Reference Electrode" which issued on Aug. 11, 1987 to Jackle is cited to show that it is known to use a reference electrode.
U.S. Pat. No. 3,654,113 entitled "Programmed Fluid Sampling and Analysis Apparatus" which issued on Nov. 24, 1972 to Bochinski shows a fluid sampling and analysis apparatus utilizing valves 30 and 40 which in one position allow circulation of a fluid and in another position send the fluid to a drain line.
None of the known prior art disclose the combination set forth herein.